Several cervical artificial disc technologies have been developed to replace degenerated intervertebral discs in the cervical spine. While no artificial disc can perfectly replace a natural disc’s ability to cushion and transfer loads in the neck, an artificial disc may maintain more of the cervical spine’s natural range of motion compared to fusion surgery.

Artificial discs are available in various sizes, shapes, and heights in order to achieve these goals and provide good surgical outcomes. Several types of discs have been fabricated using different materials, designs, and techniques.

And now a California company has just obtained FDA approval for another promising product.

Simplify® Disc is a motion-preserving cervical artificial disc designed to allow for advanced imaging capability of MRI, to better match patients’ anatomies, and for physiologic movement. The three-piece disc, with a semi-constrained mobile core, is designed to mimic/replicate the natural biomechanical motion of a healthy disc. Implantation of the Simplify Disc is accomplished in a straightforward, three-step procedure.

Simplify Medical, a privately-held company, headquartered in Sunnyvale California, focused on cervical spinal disc arthroplasty and developer of the Simplify® cervical artificial disc, announced U.S. Food and Drug Administration (FDA) Approval for the Simplify Disc Pre-Market Application (PMA) for 1-level indications. Simplify Disc achieved superiority to the fusion control on the composite primary endpoint.

The prospective trial enrolled 166 Simplify Disc patients at 16 clinical sites across the United States, and results were compared with a historical fusion control. Simplify Disc was used for 1-level cervical implantation between the C3 to C7 vertebrae.

The study results demonstrated that Simplify Disc achieved superiority in overall success compared to anterior cervical discectomy and fusion (ACDF). At 24 months:

— The Simplify Disc overall success rate of 93.0% was statistically superior to the ACDF overall success rate of 73.6% (p<.001).
— 97.9% of Simplify Disc patients achieved a significantly higher rate of meaningful (15 point) improvement in Neck Disability Index (NDI) compared to ACDF at 88.0% (p=.009).
— Simplify Disc mean NDI improved from 63.3 at baseline to 13.6 at 24 months, and was superior to ACDF at all follow-up timepoints.
— Simplify Disc patients had a higher rate of improvement in neurological function at 79.9% compared to ACDF at 54.7%.
— Simplify Disc mean VAS (Neck/Arm Pain) of 15.6 was superior to ACDF at 23.3 (p<.001).
— Significantly fewer Simplify Disc patients, 10.8%, were taking narcotic pain medication compared to ACDF patients at 36.8% (p<.001).
— Time to recovery (defined as 15 points of NDI improvement) was faster for Simplify Disc patients compared to ACDF patients. At 6 weeks, 87.0% of Simplify Disc patients and 76.8% of ACDF patients had achieved this threshold. At 3 months, 95.9% of Simplify Disc patients and 81.1% of ACDF patients had achieved recovery.
— Simplify Disc patients had less adjacent level degeneration compared to ACDF patients. At the disc level above the treatment level, 82% of Simplify Disc patients and 52% of ACDF patients had no progression in degeneration. At the disc level below the treatment level, 72% of Simplify Disc patients and 34% of ACDF patients had no progression in degeneration.

The Simplify Disc is also being evaluated in a separate IDE study in the U.S. for 2-level indications. The enrollment for the 2-level trial was completed in November 2018. Simplify Disc is limited to investigational use for this indication.

San Diego-based Phamatech, Inc. and its CEO and founder, Tuan Pham, have agreed to pay $3,043,484 to resolve allegations that they violated the False Claims Act by submitting false claims to Medicare for laboratory drug-testing services.

Phamatech is a medical technology company that manufactures diagnostic devices and provides laboratory testing including for drugs and alcohol.

The United States alleged that Phamatech improperly paid a medical clinic to induce it to refer orders for laboratory drug-testing to Phamatech and consequently received government reimbursement for those tests in violation of the federal Anti-Kickback Statute and the False Claims Act.

Specifically, the United States alleged that Phamatech paid kickbacks to Imperial Valley Wellness (“IVW”), a medical practice group, to induce IVW to order laboratory testing for its patients enrolled in Medicare. Phamatech allegedly paid IVW a per-specimen fee in exchange for IVW’s referral of urine samples from Medicare beneficiaries.

The government further alleged that many of the samples that IVW referred to Phamatech for testing under this arrangement were not medically necessary and therefore not lawfully eligible for Medicare reimbursement.

The False Claims Act allegations being resolved were originally brought in a lawsuit filed by a former employee of Phamatech, John Polanco, under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens with knowledge of fraud against the government to bring suit on behalf of the government and to share in any recovery.

Mr. Polanco will receive $517,392 from the settlement proceeds.

The investigation was conducted by the U.S. Attorney’s Office for the Southern District of California, the Department of Health and Human Services Office of Inspector General, and the Federal Bureau of Investigation.

This case is captioned United States, et al., ex rel. John Polanco v. Phamatech, Inc. and Tuan Pham, 16CV1835-L-NLS, and the matter was handled by Assistant U.S. Attorney Paul Starita of the Affirmative Civil Enforcement Unit of the U.S. Attorney’s Office.

Last Wednesday was the deadline for Gov. Newsom to act on bills lawmakers passed this year. It capped a tumultuous legislative session that was delayed three times because of the pandemic.

In a normal year, more than 1,000 bills would have made it to Newsom’s desk for his consideration. This year, it was just a few hundred.

Labor unions were disappointed to see him veto two of their biggest issues: A bill that would that sought to guarantee laid-off hospitality workers would be first in line to get their jobs back once those industries start rehiring and another that would have extended health and safety protections to domestic workers.

In a victory for business groups, Newsom vetoed Assembly Bill 3216, a proposed law that would have required that employers in certain industries – hotels, private clubs, airports or who provide building services to commercial buildings – would have rehire laid-off workers when they decided it was time to increase their workforces once again.

Newsom said in his veto message “I recognize the real problem this bill is trying to fix-to ensure that workers who have been laid off due to the COVID 19 pandemic have certainty about their rehiring and job security.”

“But, as drafted, its prescriptive provisions would take effect during any state of emergency for all layoffs, including those that may be unrelated to such emergency. Tying the bill’s provisions to a state of emergency will create a confusing patchwork of requirements in different counties at different times.The bill also risks the sharing of too much personal information of hired employees.”

Nonetheless, many of California’s largest cities – including Los Angeles, Long Beach, San Francisco and Oakland – have enacted their own rehiring ordinances in response to the pandemic. And California law already had worker retention laws for the janitorial industry and the grocery industry.

Newsom also vetoed SB 1257, a bill that would have included about 11 million California homes and apartments under Cal/OSHA’s jurisdiction.

His veto message proclaimed that “New laws in this area must recognize that the places where people live cannot be treated in the exact same manner as a traditional workplace or worksite from a regulatory perspective.“

He went on to say that “SB 1257 would extend many employer obligations to private homeowners and renters, including the duty to create an injury prevention plan and requirement to conduct outdoor heat trainings. Many individuals to whom this law would apply to lack the expertise to comply with these regulations. The bill would also put into statute a potentially onerous and protracted “investigation by letter” procedure between Cal-OSHA and private tenants and homeowners. In short, a blanket extension of all employer obligations to private homeowners and renters is unworkable and raises significant policy concerns.“

An administrative law judge has dismissed liens valued at $18 million filed by convicted medical provider Michael E. Barri, bringing to a close one of the earliest cases aimed at combatting fraud in California’s workers’ compensation system.

“The anti-fraud statutes that took effect in January 2017 were designed to prevent convicted medical providers from continuing to file lien claims and profiting from fraud,” said Division of Workers’ Compensation (DWC) Administrative Director George Parisotto. “The dismissal of millions of dollars’ worth of liens shows the strategy to fight those schemes works.”

DWC suspended Barri from participating in California’s workers’ compensation system after he pled guilty in 2016 to federal conspiracy charges and admitted receiving $206,506 in illegal kickbacks for referring dozens of patients for spinal surgeries and other medical services to Pacific Hospital of Long Beach and related entities.

The San Clemente chiropractor challenged his suspension in court and pursued collection of $18,161,362 in liens he had filed in 944 individual workers’ compensation cases through the entities he controlled.

An Appeals Court denied Barri’s writ in 2018 and upheld the anti-fraud legislation that led to his suspension, sending the matter of the liens back to the Workers’ Compensation Appeals Board (WCAB).

Administrative Law Judge Alan Skelly held several hearings in Anaheim in which the lien claimants, insurance carriers and members of the Department of Industrial Relations’ Anti-Fraud Unit were represented by counsel. Barri contested discovery related to his 944 liens, then filed a Notice of Withdrawal with Prejudice of liens of Tristar Medical Group, Jojaso Management, Inc., Michael E. Barri Chiropractic Corporation and Michael E. Barri, D.C. Judge Skelly accepted the notice and issued the order dismissing the liens.

Barri was one of many chiropractors, physicians and others who received lucrative kickbacks for each lumbar surgery and cervical fusion surgery referred to Pacific Hospital. During the last eight years of the scheme, the hospital submitted more than $580 million in fraudulent bills. Because of his referrals, Pacific Hospital billed insurance carriers approximately $3.9 million for spinal surgeries and other medical services.

Worker’s compensation reforms that went into effect in January 2017 required DWC to suspend certain medical providers from participating in the workers’ compensation system, including those who are convicted of a felony or misdemeanor involving fraud or abuse of any patient, the Medi-Cal or Medicare programs, or the workers’ compensation system itself. Labor Code section 139.21 provides for a hearing process regarding the suspension and a special lien adjudication procedure to address pending liens of those providers suspended based upon a criminal conviction.  

The Department of Industrial Relation’s (DIR’s) fraud prevention efforts are posted online, including information on lien consolidations and the Special Adjudication Unit, frequently updated lists for physicians, practitioners, and providers who have been issued notices of suspension and those who have been suspended pursuant to Labor Code §139.21(a)(1).

Some of the sweeping changes just made to the California Superior Court system will apply to depositions in worker’s compensation litigation, and will permanently allow remote depositions without consent of all parties.

The superior court system and the Appeals Board have distinct and separate rules of practice and procedures. Most of the new law will therefore not apply to worker’s compensation litigation.

But, both systems share the discovery statutes. Depositions in workers’ compensation are allowed by Labor Code section 5710 provides that “the deposition of witnesses residing within or without the state to be taken in the manner prescribed by law for like depositions in civil actions in the superior courts of this state under Title 4 (commencing with Section 2016.010) of Part 4 of the Code of Civil Procedure.”

Governor Newsom just signed Senate Bill No. 1146, a new law that makes substantial changes to litigation in superior courts. However, since some of these changes pertain to how depositions are taken in superior courts, Labor Code 5710 would make those changes applicable to discovery in worker’s compensation as well.

The new law amends Section 2025.310 of the Code of Civil Procedure, which is also specifically applicable to workers’ compensation depositions. The following are the key new provisions of the deposition process.

” A deponent is not required to be physically present with the deposition officer when being sworn in at the time of the deposition.”

“Subject to Section 2025.420, any party or attorney of record may, but is not required to, be physically present at the deposition at the location of the deponent.”

In essence, these provisions eliminate the requirement that consent is required to conduct a deposition by remote methods. Although workers’ compensation depositions have been conducted remotely since the beginning of the pandemic as a result of temporary workers’ compensation rules, the remote deposition process is now a permanent part of the litigation landscape in both civil and workers’ compensation proceedings.

Senate Bill 1146 was declared an “urgency statute” and thus takes effect immediately.